NCT01883024

Brief Summary

The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

June 14, 2013

Last Update Submit

May 22, 2023

Conditions

Type 1 Diabetes

Keywords

Real time continuous glucose monitoring, decision support software, smartphone application.

Outcome Measures

Primary Outcomes (1)

  • Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)

    Assessment of the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

    3 months

Secondary Outcomes (4)

  • Assessment of similarity between patient decisions and IPRA© advices

    3 months

  • Assessment of changes proposed by the experts

    3 months

  • Assessment of frequency of software use

    3 months

  • Assessment of patient satisfaction

    3 months

Study Arms (1)

Type 1 diabetes

OTHER
Other: A decision support softwareOther: Insulin PumpOther: Continuous glucose monitoring

Interventions

A decision support softwareOTHER
Type 1 diabetes
Insulin PumpOTHER
Type 1 diabetes
Continuous glucose monitoringOTHER
Type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women ≥ 18 years of age,
  • patients with type 1 diabetes for more than 2 years,
  • patients treated by insulin pump for more than 6 months,
  • patients using of real-time continuous glucose monitoring for more than 3 months,
  • patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
  • patient able to provide written informed consent,
  • patient able to provide written non-disclosure agreement

You may not qualify if:

  • pregnancy or breastfeeding,
  • current infectious disease,
  • patients with no smartphone® or Internet access,
  • adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud

Rennes, 35230, France

Location

Related Publications (1)

  • Esvant A, Lefebvre MA, Campillo-Gimenez B, Lannes M, Delamarre D, Guilhem I, Poirier JY. A Mobile Application Guiding Patients With Type 1 Diabetes Using Sensor-Augmented Insulin Pump Therapy. J Diabetes Sci Technol. 2016 Jun 28;10(4):985-6. doi: 10.1177/1932296816633486. Print 2016 Jul. No abstract available.

    PMID: 26902791RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion SystemsContinuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical EquipmentBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Isabelle Guilhem

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)